Trialing using physiological sensed signals for medical device implantation

Abstract

An example method includes: delivering one or more electrical stimulation pulses to one or more nerves of a patient via one or more inserted electrodes on a lead or formed on an evaluation needle and prior to implantation of an implantable medical device, the one or more nerves being associated with stimulation therapy; sensing an evoked signal generated by one or more signal sources in response to delivery of the one or more electrical stimulation pulses; determining, based at least in part on the evoked signal, a therapy response group of a plurality of therapy response groups for the patient, wherein the therapy response group indicates whether implantation of the implantable medical device is recommended; and outputting information indicative of the determined therapy response group.

What is claimed is: 
     
         1 . A system comprising:
 a device comprising processing circuitry configured to:
 deliver one or more electrical stimulation pulses to one or more nerves of a patient via one or more inserted electrodes on a lead or via a conductive portion on an evaluation needle and prior to implantation of an implantable medical device, the one or more nerves being associated with stimulation therapy; 
 sense an evoked signal generated by one or more signal sources in response to delivery of the one or more electrical stimulation pulses; 
 determine, based at least in part on the evoked signal, a therapy response group of a plurality of therapy response groups for the patient, wherein the therapy response group indicates whether implantation of the implantable medical device is recommended; and 
 output information indicative of the determined therapy response group. 
   
     
     
         2 . The system of  claim 1 , wherein to determine the therapy response group for the patient, the processing circuitry is further configured to determine the therapy response group for the patient substantially coincident with the delivery of the one or more electrical stimulation pulses. 
     
     
         3 . The system of  claim 1 , wherein to determine the therapy response group for the patient, the processing circuitry is further configured to determine the therapy response group for the patient within a time period after delivery of the one or more electrical stimulation pulses, wherein the time period includes one of:
 less than one day;   less than one hour;   less than one minute; or   less than one second.   
     
     
         4 . The system of  claim 1 , wherein the one or more nerves include one or more of sacral nerves and tibial nerves. 
     
     
         5 . The system of  claim 1 , wherein the processing circuitry is further configured to:
 determine that the evoked signal satisfies one or more criteria; and   wherein to determine the therapy response group for the patient, the processing circuitry is further configured to classify, responsive to determining that the evoked signal satisfies the one or more criteria, the patient into the therapy response group that indicates that implantation of the implantable medical device is recommended for delivering stimulation therapy to the patient.   
     
     
         6 . The system of  claim 1 , wherein the processing circuitry is further configured to:
 determine that the evoked signal does not satisfy one or more criteria; and   wherein to determine the therapy response group for the patient, the processing circuitry is further configured to classify, responsive to determining that the evoked signal does not satisfy the one or more criteria, the patient into the therapy response group that indicates that the patient is a candidate for longer term evaluation of whether to receive therapy with the implantable medical device.   
     
     
         7 . The system of  claim 1 , wherein the evoked signal comprises a second evoked signal and the one or more electrical stimulation pulses comprises a second set of one or more electrical stimulation pulses, and the processing circuitry is further configured to:
 determine that a first evoked signal, evoked prior to the second evoked signal from delivery of a first set of one or more electrical stimulation pulses delivered to a first location, does not satisfy one or more criteria; and   wherein to deliver the second set of one or more electrical stimulation pulses the processing circuitry is further configured to deliver, responsive to the determination that the first evoked signal does not satisfy the one or more criteria, the second set of one or more electrical stimulation pulses at a second location different than the first location.   
     
     
         8 . The system of  claim 1 , wherein the processing circuitry is further configured to:
 determine that the evoked signal satisfies one or more criteria, wherein the criteria includes one or more of determining whether a number of signal peaks satisfies a threshold, whether an amplitude of one or more signal peaks satisfies a threshold, whether an area under one or more signal peaks satisfies a threshold, whether a signal peak width satisfies a threshold, whether a time between signal peaks satisfies a threshold, whether a ratio of signal peak amplitudes satisfies a threshold, whether a ratio of signal peak widths satisfies a threshold, whether a ratio of areas under signal peaks satisfies a threshold, whether a latency of a signal peak satisfies a threshold, whether a number of signal valleys satisfies a threshold, whether one or more signal valley amplitudes satisfies a threshold, whether an area above a signal valley satisfies a threshold, whether a signal valley width satisfies a threshold, whether a time between signal valleys satisfies a threshold, whether a ratio of signal valley amplitudes satisfies a threshold, whether a ratio of signal valley widths satisfies a threshold, whether a ratio of areas above signal valleys satisfies a threshold, whether a signal valley latency satisfies a threshold, whether a root-mean-square signal value satisfies a threshold, whether a signal skew satisfies a threshold, whether a signal kurtosis satisfies a threshold, whether a signal frequency satisfies a threshold, whether a signal spectral content satisfies a threshold, whether a Hjorth feature satisfies a threshold, whether a signal amplitude growth curve satisfies a threshold, whether a signal amplitude growth curve inflection point amplitude satisfies a threshold, whether a signal amplitude growth curve inflection point latency satisfies a threshold, whether a signal amplitude growth curve saturation point satisfies a threshold, whether a signal strength duration curve satisfies a threshold, whether a signal maximum rate of change satisfies a threshold, or whether a signal minimum rate of change satisfies a threshold; and   wherein to determine the therapy response group for the patient, the processing circuitry is further configured to classify, based on the evoked signal satisfying the one or more criteria, the patient into the therapy response group that indicates that implantation of the implantable medical device is recommended for delivering pelvic disorder therapy to the patient.   
     
     
         9 . The system of  claim 1 , wherein the processing circuitry is further configured to:
 train a machine learning model using evoked signal data from a plurality of patients undergoing known therapy programs;   determine one or more criteria for the evoked signal based on the trained machine learning model; and   periodically retrain the machine learning model using patient therapy program data collected over a period of time.   
     
     
         10 . The system of  claim 1 , wherein the processing circuitry is further configured to:
 determine that the evoked signal satisfies one or more criteria; and   wherein to determine the therapy response group for the patient, the processing circuitry is further configured to classify, based on the evoked signal satisfying the one or more criteria, the patient into the therapy response group that indicates that the implantable medical device is a rechargeable implantable medical device.   
     
     
         11 . The system of  claim 1 ,
 wherein the device comprises a first device and the processing circuitry comprises first processing circuitry,   wherein the system further comprises a second device comprising second processing circuitry,   wherein the second processing circuitry is in communication with the first processing circuitry, and   wherein the second processing circuitry is configured to
 train a machine learning model using evoked signal data from a plurality of patients undergoing known therapy programs; 
 receive signal data of the evoked signal from the first processing circuitry; 
 determine one or more criteria for the evoked signal based on the trained machine learning model; and 
 periodically retrain the machine learning model using patient therapy program data collected over a period of time. 
   
     
     
         12 . The system of  claim 1 , wherein the processing circuitry is further configured to:
 determine that the evoked signal satisfies one or more criteria; and   wherein to determine the therapy response group for the patient, the processing circuitry is further configured to classify, based on the evoked signal satisfying the one or more criteria, the patient into the therapy response group that indicates that the implantable medical device is a non-rechargeable implantable medical device.   
     
     
         13 . The system of  claim 1 , wherein the evoked signal comprises a second evoked signal and the one or more electrical stimulation pulses comprises a second set of one or more electrical stimulation pulses, and the processing circuitry is further configured to:
 determine that a first evoked signal, evoked prior to the second evoked signal from delivery of a first set of one or more electrical stimulation pulses delivered with a first stimulation amplitude, does not satisfy one or more criteria;   wherein to deliver the second set of one or more electrical stimulation pulses the processing circuitry is further configured to deliver, responsive to the determination that the first evoked signal does not satisfy the one or more criteria, the second set of one or more electrical stimulation pulses at a second stimulation amplitude different than the first stimulation amplitude; and   output information indicative of the stimulation level at which the therapy response group was determined for the patient.   
     
     
         14 . A method comprising:
 delivering one or more electrical stimulation pulses to one or more nerves of a patient via one or more inserted electrodes on a lead or formed on an evaluation needle and prior to implantation of an implantable medical device, the one or more nerves being associated with stimulation therapy;   sensing an evoked signal generated by one or more signal sources in response to delivery of the one or more electrical stimulation pulses;   determining, based at least in part on the evoked signal, a therapy response group of a plurality of therapy response groups for the patient, wherein the therapy response group indicates whether implantation of the implantable medical device is recommended; and   outputting information indicative of the determined therapy response group.   
     
     
         15 . The method of  claim 14 , wherein determining the therapy response group comprises determining the therapy response group for the patient within a time period after delivery of the one or more electrical stimulation pulses, wherein the time period includes one of:
 less than one day;   less than one hour;   less than one minute; or   less than one second.   
     
     
         16 . The method of  claim 14 , further comprising:
 determining that the evoked signal satisfies one or more criteria; and   wherein determining the therapy response group for the patient comprises classifying, responsive to determining that the evoked signal satisfies the one or more criteria, the patient into the therapy response group that indicates that implantation of the implantable medical device is recommended for delivering stimulation therapy to the patient.   
     
     
         17 . The method of  claim 14 , wherein the evoked signal comprises a second evoked signal and the one or more electrical stimulation pulses comprises a second set of one or more electrical stimulation pulses, and the method further comprises:
 determining that a first evoked signal, evoked prior to the second evoked signal from delivery of a first set of one or more electrical stimulation pulses delivered to a first location, does not satisfy one or more criteria; and   wherein delivering the second set of one or more electrical stimulation pulses comprises delivering, responsive to determining that the first evoked signal does not satisfy the one or more criteria, the second set of one or more electrical stimulation pulses at a second location different than the first location.   
     
     
         18 . The method of  claim 14 , further comprising:
 determining that the evoked signal satisfies one or more criteria; and   wherein determining the therapy response group for the patient comprises classifying, based on the evoked signal satisfying the one or more criteria, the patient into the therapy response group that indicates that the implantable medical device is a rechargeable or non-rechargeable implantable medical device.   
     
     
         19 . The method of  claim 14 , wherein the evoked signal comprises a second evoked signal and the one or more electrical stimulation pulses comprises a second set of one or more electrical stimulation pulses, and the method further comprises:
 determining that a first evoked signal, evoked prior to the second evoked signal from delivery of a first set of one or more electrical stimulation pulses delivered with a first stimulation amplitude, does not satisfy one or more criteria;   wherein delivering the second set of one or more electrical stimulation pulses comprises delivering, responsive determining that the first evoked signal does not satisfy the one or more criteria, the second set of one or more electrical stimulation pulses at a second stimulation amplitude different than the first stimulation amplitude; and   outputting information indicative of the stimulation level at which the therapy response group was determined for the patient.   
     
     
         20 . A computer readable medium comprising instructions that, when executed, cause one or more processors to:
 deliver one or more electrical stimulation pulses to one or more nerves of a patient via one or more inserted electrodes on a lead or formed on an evaluation needle and prior to implantation of an implantable medical device, the one or more nerves being associated with stimulation therapy;   sense an evoked signal generated by one or more signal sources in response to the delivery of the one or more electrical stimulation pulses;   determine, based at least in part on the evoked signal, a therapy response group of a plurality of therapy response groups for the patient, wherein the therapy response group indicates whether implantation of the implantable medical device is recommended; and   output information indicative of the determined therapy response group.